RecruitingPhase 1NCT06738576

Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old

Phase II Clinical Trial to Determine the Safety and Efficacy of the Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106) in the Local Treatment of Female Urinary Incontinence in Women Over 50 Years of Age

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Enrollment

60 participants

Start Date

Dec 16, 2024

Study Type

INTERVENTIONAL

Conditions

Urinary Incontinence, Stress

Summary

Evaluate the feasibility and safety, obtaining initial efficacy data, of expanded allogeneic mesenchymal stem cells derived from adipose tissue (HC106) for the treatment of urinary incontinence in women over 50 years of age.

Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called allogeneic mesenchymal stem cells for people with urinary incontinence, stress. The study is currently recruiting participants at 6 locations. People eligible for this study include women aged 50 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGallogeneic mesenchymal stem cells

Cell implantation is carried out in the following steps: 1. \- Patient anesthesia 2. \- Identification of the external urinary sphincter and the incompetent area responsible for incontinence through intraurethral cystoscopy. 3. \- Resuspension of the cells by gentle manual shaking of the vials. Once the cells are resuspended, they will be used immediately. 4. \- Injection of the cell suspension with a long, fine needle (those usually used in endoscopic puncture, \<22G) at 2 points of the sphincter that will coincide with the 3 o'clock and 9 o'clock position of the hands of a clock). The injection will be superficial, trying not to go deeper than 2 mm to create a wheal in each injection visible endoscopically. 5. \- Cellular remains, if any, and the vials used will be eliminated following the usual procedures used for the management of hospital surgical waste.

DRUGPlacebo

Placebo implantation is carried out in the same way as the drug implantation